Senior CRA
ICON
Taipei
6天前

Job Responsibilities :

  • Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in phases II - III ensuring that applicable regulations and principles of ICG-GCP are adhered to.
  • Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
  • Submission of protocol, consent documents for ethics / IRB approval and assist in preparing regulatory submissions as requested.
  • Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.
  • Managing sponsor generated queries efficiently and responsible for study cost effectiveness Dependent on level of experience you may assist in training and mentoring less experienced CRA's and / or manage CRA's working on international projects
  • Experience and Qualification

  • 36 months+ of monitoring experience in phase I III trials as a CRA
  • Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
  • Native local language and conversational English is a must
  • Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
  • Ability to produce accurate work to tight deadlines within a pressurized environment
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